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Merck gets US green light for allergy immunotherapy

Expected to provide a significant boost to company's partner Alk-Abello

US Food and Drug Administration (FDA)Merck & Co and Alk-Abello have been given the go-ahead by the US FDA to start selling their grass pollen allergy immunotherapy Grastek.

The US regulator approved Grastek for the treatment of Timothy grass pollen-induced allergic rhinitis with or without conjunctivitis. The product takes the form of an allergen extract given as a sublingual tablet that, over time, reduces the body's reaction to the allergen.

The approval was expected given that the FDA's Allergenic Products Advisory Committee voted unanimously to recommend its approval in December, although labelling for the new product will include a boxed warning detailing a link between the product and severe allergic reactions.

Grastek is the second allergy immunotherapy (AIT) product to be cleared for marketing in the US after Stallergenes' Oralair, which was approved last month. Merck was given the nod for the product in Canada earlier this year and it has been sold by Alk-Abello as Grazax in Europe since 2006.

Analysts are divided about the US commercial potential for Grastek, which is positioned as a patient-friendly alternative to current immunotherapeutic approaches which rely on a series of allergen injections. However, a number - including Jyske Bank - believe that sales of around $250m a year are possible, which would make it a minor product for Merck but a significant boost to Alk-Abello. 

"Every grass pollen season, many patients with moderate to severe allergic rhinitis experience nasal and ocular allergy symptoms at their worst while taking symptom-relieving medication," commented David Bernstein of the University of Cincinnati.

Patients often have multiple sensitivities and, while some may be candidates for immunotherapy, a portion decline allergy shots.

The FDA is also reviewing Merck and ALK-Abello's ragweed allergy Ragwitek, which was backed by the agency's advisory panel in January. A final decision on the ragweed product is expected mid-year.

Article by
Phil Taylor

15th April 2014

From: Sales



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